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BG Medicine, FDA Partner on Liver Toxicity Biomarker Study

NEW YORK, Oct. 25 (GenomeWeb News) - BG Medicine said today that it has submitted a cooperative research and development agreement with the US Food and Drug Administration's National Center for Toxicological Research for a project to discover biomarkers of human hepatotoxicity.

 

BG Medicine said that it has jointly designed the project, called the Liver Toxicology Biomarker Study, with the FDA "with input from a number of pharmaceutical companies." The company said that the study will be funded by pharmaceutical manufacturers, who will receive "a paid-up perpetual license to any biomarkers discovered and access to all project data."

 

The LTBS will be conducted at the FDA's NCTR laboratory in Jefferson, Ark., and at BG Medicine in Waltham, Mass., where the organizations will rely on a range of technologies, including functional genomics, proteomics, metabolomics, and computational analysis.

 

BG Medicine said it expects the project to result in improved tests for liver toxicity, which is the most common biological reason for drug failure in the development of new drugs. Current toxicity testing methods "often fail to identify human liver toxicity issues," the company said. "Consequently, liver toxicity is often detected for the first time when drugs are in phase 2 of clinical testing after tens of millions of dollars or more have been spent on a drug."

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